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Lantidra’s First-Cycle Complete Response Letter Centered On Inspection And Product Quality Issues

 
• By Sue Sutter

Although the CRL delayed the cell therapy’s approval by almost two years, additional CMC-related testing requested by the FDA ultimately came to be seen as a good thing by sponsor CellTrans because it provided assurance of product consistency.

Drug Review Profile: Lantidra
CellTrans had to address a host of product quality deficiencies before approval. • Source: Pink Sheet/Shutterstock

Product quality issues that led to a nearly two-year delay in approval of CellTrans, Inc.’s Lantidra (donislecel-jujn) for type 1 diabetes reflect the challenges small sponsors of novel and complex biological therapies face in getting their manufacturing programs ready to satisfy regulatory expectations.

Donislecel, a cellular therapy product containing purified allogeneic deceased donor pancreas derived islets of Langerhans for transplant, gained a favorable recommendation from the US Food and Drug Administration’s Cellular, Tissue and Gene Therapies Advisory Committee in April 2021. The panel voted 12-4 with one abstention that the product had an overall favorable benefit-risk ratio for some patients with T1D

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More from Drug Review Profiles

Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
• By Sue Sutter

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.

Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
• By Sue Sutter

Agency staff repeatedly said the BLA based on a single-arm study in 55 patients lacked substantial evidence of effectiveness in steroid-refractory acute graft-versus-host disease and a randomized trial was needed, but changed course “based on additional consideration” after a second CRL.

Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
• By Sue Sutter

The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.

Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

 
• By Bridget Silverman

The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products.

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Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.